By Steven Reinberg and Margaret Steele
THURSDAY, Oct. 11 (HealthDay News) -- Twelve people have now died and 137 have been sickened in the national meningitis outbreak apparently linked to contaminated steroid injections, U.S. health officials reported Wednesday.
In the wake of the outbreak, members of Congress are calling for more regulatory oversight of the type of smaller, "compounding" pharmacy that distributed the steroid shots. And new information about the regulatory history of the company tied to the outbreak has begun to emerge.
All of the patients affected were thought to be injected with methylprednisolone acetate, a steroid drug commonly used for back pain that investigators suspect was tainted with a fungus usually found in leaf mold, according to the U.S. Centers for Disease Control and Prevention.
Health officials in the 23 states that received shipments of the steroid are trying to track down patients who got the injections. As many as 13,000 people may have gotten the shots, U.S. health officials have said.
The steroid was manufactured by a specialty pharmacy, New England Compounding Center of Framingham, Mass., which last month voluntarily recalled three lots of the steroid. It has since shut down operations and stopped distributing its products, health officials said.
According to story Thursday by the Associated Press, this is not the first time New England Compounding Center has encountered problems with contaminated vaccines. In 2007, the company settled a lawsuit that claimed that an 83-year-old man died in 2004 after contracting fatal bacterial meningitis from a shot produced by the compounding center. The pharmacy reached a settlement with the man's widow before the case went to trial, the AP said.
Another company, Ameridose, based in Westborough, Mass., has the same owners as New England Compounding Center and voluntarily shut down Wednesday for inspections. According to the AP, a business customer had recently complained that Ameridose neglected to separate sterile and non-sterile products it had warehoused.
According to The New York Times, New England Compounding Center is relatively small, with 49 employees. Compounding pharmacies are not subject to the same oversight from the U.S. Food and Drug Administration as regular drug stores are, and members of Congress now say the outbreak points to a need for more regulatory control.
"This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," according to a statement by Rep. Henry Waxman, (D-Calif.) and two other Democrats on the House Energy and Commerce Committee, Rep. Diana DeGette of Colorado and Rep. Frank Pallone Jr. of New Jersey, the Times reported.
Republicans form the majority on the committee, but a spokeswoman for Republican committee chair Fred Upton of Michigan, told the Times that he and three other Republican members would join a request for an inquiry.
And Rep. Edward Markey, a Massachusetts Democrat who represents the district that's home to New England Compounding Center, said he would push for legislation that requires certain pharmacies that distribute products across state lines to register with the FDA.
According to the Associated Press, it is still not known how many of the steroid shots were contaminated with the fungus that causes this rare type of meningitis, so it's not clear how many people might be at risk of infection.
The 13,000 figure includes not only people who got the shots for back pain and are considered most at risk, because meningitis is inflammation of tissue surrounding the brain and spinal cord. Other patients got injections in other parts of the body, such as knees and shoulders.
There was no breakdown on the number of back injections, said Curtis Allen, a spokesman for the CDC.
On Wednesday, the CDC offered the following state-by-state breakdown of cases: Florida: 6 cases, including 1 death; Indiana: 15 cases; Maryland: 9 cases, including 1 death; Michigan: 28 cases, including 3 deaths; Minnesota: 3 cases; New Jersey: 2 cases; North Carolina: 2 cases; Ohio: 1 case; Tennessee: 44 cases, including 6 deaths; Virginia: 27 cases, including 1 death.